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A Clinical Trial of Fluvoxamine for Melancholia

L

Lingjiang Li

Status and phase

Unknown
Phase 2

Conditions

Endogenous Depression
Melancholia
Depressive Disorder

Treatments

Drug: Fluvoxamine

Study type

Interventional

Funder types

Other

Identifiers

NCT04160377
19-08-01-XY-0001

Details and patient eligibility

About

This study aims at investigating the special effectiveness of antidepressant effect of Fluvoxamine for endogenous depression. The investigators also aim to assess the effect of Fluvoxamine on the multimodal magnetic resonance imaging(MRI), blood cytokines, feces bacteria flora and neuropsychological performance in depression patients with melancholic features. The investigators further aim to identify the predictors of Fluvoxamine's antidepressant effeect using the above techniques.

Full description

This study aims at investigating the special effectiveness of antidepressant effect of Fluvoxamine for melancholia. The investigators also aim to assess the effect of Fluvoxamine on the multimodal magnetic resonance imaging(MRI), blood cytokines, feces bacteria flora and neuropsychological performance in depression patients with melancholic features. The investigators further aim to identify the predictors of Fluvoxamine's antidepressant effeect using the above techniques.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Adult (18-55 years, both sexes), with DSM-4 criteria for MDD without psychosis, as determined by a structured clinical interview Mini International Neuropsychiatric Interview
  • Moderate to severe depression, as defined by a pretreatment score ≥17 on the HDRS-17 scale
  • Informed consent to participate in this study
  • ethinic Han, right-handed, Junior high school education or above

Exclusion criteria

  • A history of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses; active suicidal intention, as determined by clinical interview
  • Active or recent (<12 months) substance abuse or dependence; excluding nicotine
  • Presence of ECT treatment in recent 6 months
  • period of pregnancy or lactation
  • hearing disorder or colour blindness
  • Immediate relatives have bipolar disorder or mania disorder

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

melancholic depression
Experimental group
Description:
patients with melancholic depression undergo the treatment of Fluvoxamine
Treatment:
Drug: Fluvoxamine
non-melancholic depression
Experimental group
Description:
patients with non-melancholic depression undergo the treatment of Fluvoxamine
Treatment:
Drug: Fluvoxamine

Trial contacts and locations

1

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Central trial contact

Xueqin Li

Data sourced from clinicaltrials.gov

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